Drug Safety and Pharmacovigilance Essential Skills
For a Drug Safety Associate and for all other titles in the Pharmacovigilance department, few skills are mentioned below which are extremely essential.
1.Case Assessment: Each individual case is assessed over it’s –
- Seriousness assessment
- Causality assessment
- Expectedness assessment
The drug safety professional will gauge if the reported adverse event contains the seriousness criterias or it’s non serious. The professional should also be able to determine a causal relationship between the adverse event and the drug consumed. This skill is essential for evaluation of the benefit-harm profile of the drug and signal detection. Expectedness assessment involves the beforemention of the adverse reactions in the Reference Safety Information (RSI) document of the said drug. To specifically decide if the reported ADR is expected or unexpected can be unobvious at times. Through training and the experience of numerous case assessments in the pharmacovigilance team one gains this insight.
2.MedDRA : Medical Dictionary for Regulatory Activities .MedDRA is the standardized international medical dictionary which is used for regulatory communication and evaluation of all the data pertaining to medical products for human use. The principle is to have a conformed language across countries, companies and the regulatory bodies globally. MedDRA and its applications like coding, retrieval, and analysis of clinical data is an expected and an essential skill for a Pharmacovigilance professional. MedDRA is endorsed by ICH and maintained by MSSO (Maintenance and Support Service Organization). .
3. Query Generation : Also called as follow up depending on the Organization the drug safety professional is working for.After the case is triaged and entered by the data entry personnel – the query generation process for the follow up starts. The data entry personnel would raise/generate a query if important details are missing. A medical reviewer’s decision is pivotal in deciding whether more information (due to incomplete details) is required or not. Then the case is transferred as per the work flow states.
Query generation is pertinent for spontaneous ICSRs and Serious Adverse Events. The skill set for generating a query by the data entry personnel and the Drug safety Physician is extremely essential in pharmacovigilance.
4. Narrative writing: Drug Safety Associates build up a case narrative, which is a brief summary of specific medical events experienced by the patient during the course of a clinical trial/ treatment. The summary aims to determine the causal relationship between the drug and the adverse event.The skill to be concise and give apt information is a necessity in drug safety.
5. Report Generation : E2B Submissions and Transmissions
All the Individual case safety reports (ICSRs) need to be submitted electronically to the concerned pharmacovigilance regulatory bodies (example – FDA or MHRA). ARGUS – a popular safety database platform is often used by companies to generate and submit the case report. Adherence to the various timelines when doing the submissions in an electronic file format is an important skill to acquire in Drug Safety.
To learn and acquire the above mentioned skills, visit https://medipharmsolutions.com Or call us at 848-230-0240.
